MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1508275-18

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported that prior to use when flushing the 2.75x18mm xience pro stent delivery system (sds) a leak of contrast and saline occurred from the balloon.No manipulation of the stent was noted and normal force was applied removing the sheath/stylet, yet the stent was noted to be moved on the balloon.The sds was not used.A new xience stent was used to complete the procedure.There was no patient involvement and no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported stent dislodgement and leak/splash could not be confirmed.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents.A conclusive cause for the reported difficulties could not be determined.Stent dislodgement prior to use may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with accessory devices.Factors that may contribute to a leak include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the balloon, guide wire and/or inflation lumen.Based on the information received and analysis of the returned device, a conclusive cause for the reported stent dislodgement and leak/splash cannot be determined.In addition, it is possible the observed material deformation (stent damage) may have occurred due to inadvertent mishandling during sheath/stylet removal or unpackaging of the device¿ however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

Event Description

Subsequent to the initial reports, the xience pro device was received.Although returned device analysis noted no leak or stent movement, additional follow up with the account indicated the correct device was returned.

• Brand Name: XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18636627
• MDR Text Key: 334490139
• Report Number: 2024168-2024-01385
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648295300
• UDI-Public: (01)08717648295300(17)260518(10)3053041
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1508275-18
• Device Lot Number: 3053041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1